Cost-effectiveness and cost-utility of add-on, low-dose prednisolone in patients with rheumatoid arthritis aged 65+: The pragmatic, multicenter, placebo-controlled GLORIA trial.


Journal

Seminars in arthritis and rheumatism
ISSN: 1532-866X
Titre abrégé: Semin Arthritis Rheum
Pays: United States
ID NLM: 1306053

Informations de publication

Date de publication:
12 2022
Historique:
received: 26 07 2022
revised: 28 09 2022
accepted: 19 10 2022
pubmed: 7 11 2022
medline: 23 11 2022
entrez: 6 11 2022
Statut: ppublish

Résumé

The GLORIA placebo-controlled trial found a favorable balance of benefit and harm for two years of prednisolone (5 mg/day) as add-on treatment for rheumatoid arthritis (RA) patients aged 65+. This study evaluated the cost-effectiveness of low-dose prednisolone in the treatment of RA. The economic evaluation had a societal perspective with a time horizon of two years. Cost data were collected with questionnaires and from recorded events, and valued with standard Dutch unit prices of 2017. The primary effectiveness outcome was the disease activity score in 28 joints (DAS28). For cost-utility, quality-adjusted life years (QALYs) were estimated from the EuroQol-5 Dimension (EQ-5D) questionnaire. Bootstrapping assessed the uncertainty around the average differences in costs and health outcomes. In total, 444 of 451 randomized patients were included in the modified intention-to-treat analysis. Patients had median four active comorbidities at baseline. Mean total costs over two years were k€10.8 in the prednisolone group, k€0.5 (95% CI -4.0; 1.8) lower than in the placebo group. Total direct medical costs were k€0.5 (95% CI -4.0; 1.5) lower in the prednisolone group. The mean number of QALYs was similar in both groups (difference 0.02 [-0.03; 0.06] in favor of prednisolone). The DAS28 was 0.38 lower in the prednisolone group than in the placebo group (0.19; 0.56). With greater effectiveness (DAS28) at non-significantly lower costs, low-dose, add-on prednisolone is cost-effective for RA compared to placebo over two years. QALYs were equal in both groups, most likely due to the impact of multiple comorbidities.

Sections du résumé

BACKGROUND
The GLORIA placebo-controlled trial found a favorable balance of benefit and harm for two years of prednisolone (5 mg/day) as add-on treatment for rheumatoid arthritis (RA) patients aged 65+. This study evaluated the cost-effectiveness of low-dose prednisolone in the treatment of RA.
METHODS
The economic evaluation had a societal perspective with a time horizon of two years. Cost data were collected with questionnaires and from recorded events, and valued with standard Dutch unit prices of 2017. The primary effectiveness outcome was the disease activity score in 28 joints (DAS28). For cost-utility, quality-adjusted life years (QALYs) were estimated from the EuroQol-5 Dimension (EQ-5D) questionnaire. Bootstrapping assessed the uncertainty around the average differences in costs and health outcomes.
RESULTS
In total, 444 of 451 randomized patients were included in the modified intention-to-treat analysis. Patients had median four active comorbidities at baseline. Mean total costs over two years were k€10.8 in the prednisolone group, k€0.5 (95% CI -4.0; 1.8) lower than in the placebo group. Total direct medical costs were k€0.5 (95% CI -4.0; 1.5) lower in the prednisolone group. The mean number of QALYs was similar in both groups (difference 0.02 [-0.03; 0.06] in favor of prednisolone). The DAS28 was 0.38 lower in the prednisolone group than in the placebo group (0.19; 0.56).
CONCLUSION
With greater effectiveness (DAS28) at non-significantly lower costs, low-dose, add-on prednisolone is cost-effective for RA compared to placebo over two years. QALYs were equal in both groups, most likely due to the impact of multiple comorbidities.

Identifiants

pubmed: 36335684
pii: S0049-0172(22)00160-3
doi: 10.1016/j.semarthrit.2022.152109
pii:
doi:

Substances chimiques

Prednisolone 9PHQ9Y1OLM

Types de publication

Randomized Controlled Trial Multicenter Study Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

152109

Informations de copyright

Copyright © 2022. Published by Elsevier Inc.

Déclaration de conflit d'intérêts

Declaration of Competing Interests DO: Abbvie, Pfizer, MSD, Novartis, Eli Lilly, Ewo Pharma, UCB; FB: Abbvie, AstraZeneca, Gruenenthal, Horizon Therapeutics, Mundipharma, Pfizer, Roche; RB: Abbvie, Galapagos, Novartis, Pfizer; WFL: Pfizer, Galapagos, Lilly, Amgen, UCB; MB: Novartis.

Auteurs

L Hartman (L)

Amsterdam Rheumatology and Immunology Center, Amsterdam University Medical Centers, Vrije Universiteit, Amsterdam, the Netherlands; Department of Epidemiology & Data Science, Amsterdam University Medical Centers, Vrije Universiteit, Amsterdam, the Netherlands. Electronic address: l.hartman@amsterdamumc.nl.

M El Alili (M)

Department of Health Sciences, Amsterdam Public Health, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.

M Cutolo (M)

Laboratory of Experimental Rheumatology and Academic Division of Clinical Rheumatology, Department of Internal Medicine, University of Genova, Genoa, Italy.

D Opris (D)

Carol Davila University, Bucharest, Romania.

Jap Da Silva (J)

Reumatologia, Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal; Institute for Clinical and Biomedical Research (i.CBR), Faculty of Medicine, University of Coimbra, Portugal.

Z Szekanecz (Z)

Department of Rheumatology, Institute of Medicine, University of Debrecen Faculty of Medicine, Debrecen, Hungary.

F Buttgereit (F)

Department of Rheumatology and Clinical Immunology, Charité - University Medicine Berlin, Berlin, Germany.

P Masaryk (P)

National Institute for the Rheumatic Diseases, Piešťany, Slovakia.

R Bos (R)

Department of Rheumatology, Medical Center Leeuwarden, Leeuwarden, the Netherlands.

M R Kok (MR)

Department of Rheumatology and Clinical immunology, Maasstad Hospital, Rotterdam, the Netherlands.

S Paolino (S)

Laboratory of Experimental Rheumatology and Academic Division of Clinical Rheumatology, Department of Internal Medicine, University of Genova, Genoa, Italy.

Vmh Coupé (V)

Department of Epidemiology & Data Science, Amsterdam University Medical Centers, Vrije Universiteit, Amsterdam, the Netherlands.

W F Lems (WF)

Amsterdam Rheumatology and Immunology Center, Amsterdam University Medical Centers, Vrije Universiteit, Amsterdam, the Netherlands.

M Boers (M)

Department of Epidemiology & Data Science, Amsterdam University Medical Centers, Vrije Universiteit, Amsterdam, the Netherlands.

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Classifications MeSH